The following data is part of a premarket notification filed by Nexa Orthopedics, Inc. with the FDA for Futura Biomedical Metal Hemi Toe Implant.
| Device ID | K971047 |
| 510k Number | K971047 |
| Device Name: | FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT |
| Classification | Prosthesis, Toe, Hemi-, Phalangeal |
| Applicant | NEXA ORTHOPEDICS, INC. 9369 CARROLL PARK DR., SUITE A San Diego, CA 92121 |
| Contact | Jamal D Rushdy |
| Correspondent | Jamal D Rushdy NEXA ORTHOPEDICS, INC. 9369 CARROLL PARK DR., SUITE A San Diego, CA 92121 |
| Product Code | KWD |
| CFR Regulation Number | 888.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-21 |
| Decision Date | 1997-06-20 |
| Summary: | summary |